This invention is related to a diagnostic assay useful for determining which individuals afflicted with gross cystic disease of the breast will develop breast cancer.
Approximately 200,000 women develop breast cancer each year. It is the leading cause of death of women under 40 years of age. Early detection and treatment are the keys to survival from this disease. Mammography and self-examination are important factors in early detection of this disease. However, no independent biological measurements have yet been developed which can be used to determine which individuals will develop breast cancer.
Cystic breast disease is a common condition in premenopausal women, occurring predominantly in women between the ages of 30 and menopause. Patients afflicted with gross cystic disease of the breast have an approximately 2-4 fold increased incidence of breast carcinoma when compared to women without cysts. Approximately 10-20% of those afflicted with gross cystic disease have been found to go on to develop breast cancer.
Fluid derived from the breasts of human females with gross cystic disease contains a broad spectrum of biological molecules. In particular, human breast cyst fluid has been found to contain high concentrations of materials which cross-react with antibodies directed against digoxin in specific radioimmunoassay procedures for this cardiac glycoside. U.S. Pat. application Ser. Nos. 939,552 and 130,805, filed Dec. 9, 1986 and Dec. 9, 1987, respectively both of Fred I. Chasalow and H. Leon Bradlow disclose a biologically active agent isolated from Type 1 human breast cyst fluids which cross reacts with digoxin antibodies and has anti-hypertensive activity in mammals.
U.S. Pat. No. 4,440,863 issued Apr. 3, 1984 of Haagensen, Jr. discloses a glycoprotein isolated from breast cyst fluid and also detected in the serum of breast cancer patients. However, the assay for this glycoprotein was said to be insensitive for detection of early breast carcinoma.
What is needed in the art is a method for determining which of those women afflicted with gross cystic disease are at increased risk for developing breast cancer over and above the risk associated with cystic disease itself.
It is an object of the present invention to provide a method for diagnosing those individuals at increased risk for developing breast cancer.